Cardiac biopsy instrument



Sept. 19, 1967 R.T. BULLOCH 3,342,175

v CARDIAC BIOPSY INSTRUMENT Filed Nov. 23, 1964' 2 Sheets-Shet 1 INVENTOR RobertT. Bulloch M JWK ATTORNEYS Sept. 19, 1967 T. BULLOCH CARDIAC BIOPSY INSTRUMENT Filed Nov. 23, 1964 2 Sheets-Sheet V2 INVENTOR Robert T. Bulloch Ma /8 L.

ATTORNEYS United States Patent 3,342,175 CARDIAC BIOPSY INSTRUMENT Robert T. Bulloch, 5518 A St., Apt. 4, Little Rock, Ark. 72205 Filed Nov. 23, 1964, Ser. No. 413,047 6 Claims. (Cl. 128-2) ABSTRACT OF THE DISCLOSURE An intracardiac biopsy device including a curved stainless steel tube or sheath, a transversely extending handle at one end of the sheath aligned with the plane of the curve, and a wire extending through the sheath terminating at one end in a specimen cutter and being provided at the other end with a removable manipulating handle. The wire is longer than the sheath, the diameter of the sheath is small enough to be passed through a catheter in a jugular vein, and the length of the sheath is greater than the length of the jugular vein between the heart and the clavicle.

This invention relates to medical instruments and particularly to an instrument for safely taking a specimen of cardiac muscle in human patients.

The study and treatment of heart diseases, and particularly primary myocardial disease, has long been hampered because it has not been possible to safely and reliably obtain heart tissue specimens from intact, unanesthetized human patients. Though efforts have been made heretofore to achieve cardiac biopsy, it has not been considered practical, prior to the present invention, to obtain myocardial tissue routinely from living patients.

It is accordingly a general object of the invention to devise an instrument which can be used with dependable safety to take specimens of cardiac tissue from living patients.

Another object is to provide a simple, effective and reliable instrument for accomplishing intracardiac biopsy.

A further object is to provide a biopsy needle which can be introduced into the right ventricle of the human heart with safety and relative ease in such manner that the specimen cutting means of the biopsy needle is accurately positioned on the lower ventricular septum and extends in a specifically predetermined direction.

In order that the manner in which these and other objects are attained in accordance with the invention can be understood in detail, one particularly advantageous embodiment of the invention will be described with reference to the accompanying drawings, which form a part of this specification, and wherein:

FIG. 1 is a semi-diagrammatic view showing a biopsy instrument in accordance with the invention in use for obtaining a specimen of myocardial tissue;

FIG. 2 is a side elevational view, partly in longitudinal cross section, of the instrument of FIG. 1;

FIG. 3 is aview taken on line 3-3, FIG. 2;

FIG. 4 is a longitudinal sectional view of a manipulating member forming part of the instrument of FIG. 1;

FIG. 5 is a longitudinal sectional view of the distal end portion of the instrument; and

FIGS. 6 and 7 are transverse cross-sectional views taken respectively on lines 6-6 and 7-7, FIG. 5.

FIGS. 3-5 being enlarged in comparison with FIG. 2.

Referring now to the drawings in detail, and first to FIGS. 25, the embodiment of the invention illustrated comprises a tubular needle sheath 1 having a handle member 2 secured rigidly to one end thereof, the other end of the sheath being in the form of a straight portion 3 of significantly larger diameter than the main body of the sheath. The needle comprises a wire 4 which extends oompletely through the main body of sheath 1, the wire being of such length that, when one end thereof is disposed at portion 3 of the sheath, the other end portion 5 of the wire projects for a substantial distance beyond the end of the sheath to which handle member 2 is secured.

At end portion 5, the wire is equipped with a detachable manipulating member indicated generally at 6 and shown in detail in FIG. 4. Member 6 comprises a rigid cylindrical body having a portion 7 of larger diameter and a portion 8 of smaller diameter. A cylindrical bore 9, of such diameter as to snugly embrace end portion 5 of wire 4, extends completely through body portion 8 and terminates short of the tip of body portion 7. A straightwalled slot 10 is provided in body portion 7 and extends longitudinally of the manipulating member, opening both into bore 9 and through the outer surface of body portion 7. A locking cam 11 is rotatably mounted in slot 10, as by pin shaft 12, and has a high point or cam nose 11a of such size and disposition as to engage wire 4 and force the same laterally against the wall of bore 9 to lock member 6 rigidly to the wire. An operating handle 13 is rigidly secured to cam 11 so that the operator can conveniently rotate the cam to lock the member 6 to the wire and also to release the member 6 for removal preparatory to withdrawal of the wire from the sheath.

At its other end, wire 4 is rigidly secured to a specimen cutting device comprising two complementary blade members 14 and 15 each cut from thin-walled steel tubing of a diameter to embrace wire 4. Each blade member is welded at one end to the end portion of wire 4 and, at its other end, is ground along line 16 to receive a generally wedge-shaped tip member 17 which is welded in place. Members 17 are identical, each presenting a specimen-retaining shoulder 18 and a flat face 18a which slants forwardly and outwardly, terminating in a peripheral cutting edge. The surfaces of shoulder 18 and face 18a intersect to form a sharp edge adapted to aid in retaining the specimen. Since faces 18a diverge, the blade members are spread apart resiliently as they are forced into the area from which the specimen is to be taken. The blade members 14 and 15 are of equal length, and the total length of the cutting device is such that the entire cutting device can be retracted within the enlarged straight portion 3 of the sheath and protected thereby, both before and after taking of the specimen.

Advantageously, the main body of sheath 1 is a thinwalled steel tubing. Surgical steel tubing of 16-l8 gauge serves admirably for this portion of the device. The straight distal end portion 3 can be of larger diameter steel tubing, such as, 1415 gauge. The thinner, smaller diameter main body portion of the sheath, when made of 18 gauge steel tubing, for example, has adequate resilient flexibility to allow easy passage through a catheter, yet has sufficient rigidity to retain a normal, predetermined configuration which assists in achieving precise control of the alignment of the specimen cutting device. The enlarged distal end portion 3, when made of 14 gauge steel tubing, for example, is stiffer than the smaller diameter main body portion, and has suificient rigidity to retain a straight condition, extending axially in a direction determined by the configuration of the adjacent end portion of the main body of the sheath, as hereinafter described. Since portion 3 is straight, and since the outer edges of the blade members 14 and 15 of the cutting device are straight and are closely confined by portion 3, the directional orientation of the specimen cutting device is determined with preciseness by the disposition of portion 3 of the sheath. The tip of portion 3 is cut at an acute angle relative to the central axis of portion 3 and is back ground to assure easy traversal of the sheath through a catheter.

Considering FIGS. 2 and 3, it will be seen that, when sheath 1 is in its normal undistorted condition, the lower portion thereof curves in two directions which are generally at right angles to each other. Thus, the sheath has a normally straight portion or shank 1a and a normally doubly curved portion 1b, the latter terminating at the enlarged, straight distal end portion 3. Port-ion 1b is curved in a first direction (to the right, as viewed in FIG. 2) to such an extent that the straight distal end portion 3 extends at an angle a of 3090 advantageously approximately 50, downwardly and away from portion 1a. As seen in FIG. 3, portion 1b also curves in a second direction (upwardly as viewed in FIG. 3 and away from the viewer as viewed in FIG. 2) to such an extent that the straight distal end portion 3 slants at an angle 1: of -l5 away from the plane of the first-mentioned direction of curvature. This doubly curved configuration of the lower portion of the sheath is of particular importance in achieving the necessary accurate placement of the specimen cutting device on the lower ventricular septum, with blades 14 and projecting in a posteriomedial direction.

Handle member 2, rigidly fixed to sheath 1, is elongated in a direction transverse to the sheath. As seen in FIG. 3, the handle member 2 is precisely oriented so that its long dimension extends in alignment with the straight distal end portion 3. Thus, if portion 3 be considered as extending at angle b relative to a plane containing straight sheath portion 1a, then the long dimension slants from that plane at the same angle b and in the same direction, so as to provide a dependable indication of the disposition of distal end portion 3, and thus of the specimen cutter, within the patient. End portion 2a can be pointed, as seen in FIG. 3, to serve more clearly as an indicating means.

The manner in which the instrument is used to take a specimen from the ventricular septum is illustrated in FIG. 1. Employing local anesthesia, a radiopaque catheter is introduced into the right external or internal jugular vein and advanced, under fluoroscopic observation, into the right ventricle of the patients heart. The instrument is prepared as seen in FIGS. 25, with manipulating member 6 securely clamped to the proximal end of wire 4 and with the specimen cut-ting device fully retracted into the enlarged distal end portion 3 of the sheath. Employing handle member 2 both as a means for manipulating the instrument and as means for indicating the position of the specimen cutting device, the distal end portion 3 of the instrument is introduced into the catheter and the instrument advanced through the catheter until portion 3 projects from the distal end of the catheter and is positioned with its tip against the lower right ventricular septum. The specimen is then taken by forcing manipulating member 6 downwardly, causing wire 4 to drive the specimen cutting device out of sheath portion 3 to cut the specimen. With member 6 held stationary, member 6 is then manipulated to drive the needle sheath 1 over wire 4 toward the distal end of the needle, so that the enlarged portion 3 moves forwardly and again completely surrounds the specimen cutting device. Forward telescopic movement of sheath portion 3 over the specimen cutting device, such forward movement causing the sharpened leading edge of portion 3 to shear away any uncut portions of the specimen, so that the specimen is easily and clearly detached as the needle is withdrawn. The entire instrument is then removed via the catheter. The instrument having been recovered, handle 13 is rotated to free member 6 and that member is removed. The combination of the specimen cutting device and wire 4 is then withdrawn from the sheath 1 via end portion 3, and the specimen removed from the cutting device, ready for analysis. All parts of the instrument can then be cleaned easily and reassembled.

Though a particularly advantageous embodiment of the invention has been illustrated and described, it will be understood that various changes and modifications can be made therein without departing from the scope of the invention as defined in the appended claims.

What is claimed is:

1. An instrument for accomplishing intracardiac biopsy of the ventricular septum, comprising an elongated tubular needle sheath of a diameter such that the needle sheath can be passed through a catheter;

said sheath being resiliently distortable before entry into a body to perform the biopsy but capable of normally retaining a predetermined shape while within the body and during biopsy sampling,

the length of said sheath being adequate to allow the same to extend from an exterior point to the ventricular septum via the right external jugular vein of a patient,

said sheath having a proximal end and a distal end;

a handle member fixed to said sheath at the proximal end thereof and including indicating means projecting laterally relative to said sheath;

a flexible wire extending through said sheath and having one end portion projecting from the proximal end thereof;

a manipulating member secured to said one end portion of said wire and disposed exteriorly of said sheath, whereby said wire can be moved reotilinearly relative to said sheath; and

specimen cutting means secured to the other end portion of said wire for cleanly severing a tissue sample,

said cutting means comprising two blade portions movable toward each other to cooperatively grip and cleanly sever the tissue sample;

the length of said wire being greater than the length of said sheath by an amount such that said manipulating member can be moved between a first position spaced from the proximal end of said sheath to a position adjacent the proximal end of the sheath in order to cause said cutting means to remove a specimen of cardiac muscle without artifact,

said cutting means being retracted within the distal end portion of said sheath when said manipulating member occupies said first position;

the portion of said sheath adjacent the distal end thereof being curved, when said sheath is in its normal predetermined shape, in a lateral direction, said indicating means being aligned with the tip of said distal end portion to enable the user to accomplish remotely the accurate placement of said cutting means on the lower ventricular septum.

2. An instrument according to claim 1, wherein said sheath is curved, when in its normal predetermined shape, in two lateral directions which are generally at right angles to each other;

the tip of said distal end portion of said sheath, when in its normal predetermined position, extending at an angle of 30-90 relative to the axis of said sheath in one of said lateral directions and at an angle of 10-15 in the other of said lateral directions.

3. An instrument according to claim 2, wherein said tip extends at an angle of approximately 50 in said one lateral direction.

4. An instrument according to claim 1, and further comprising means detachably securing said manipulating member to said wire, whereby said manipulating member can be removed and said wire withdrawn from said sheath via the distal end thereof.

5 6 5. An instrument according to claim 4, wherein References Cited the tip of said distal end portion of said sheath is a UNITED STATES PATENTS straight tubular portion of significantly larger diarneter than the main body of said sheath, the length of 2839049 2 2 MacLean 128' 2 said tubular portion being such that said cutting 5 2,739,585 6 W 1282 means can be fully accommodated thereby. 2,767,703 10/1956 Nleburgs 6. An instrument according to claim 1, wherein I J said sheath is a thin-Walled stainless steel tube and said RICHARD GAUDET Puma), Exmmne" Wire is of stainless steel. SIMON BRODER, Examiner. 

1. AN INSTRUMENT FOR ACCOMPLISHING INTRACARDIAC BIOPSY OF THE VENTRICULAR SEPTUM, COMPRISING AN ELONGATED TUBULAR NEEDLE SHEATH OF A DIAMETER SUCH THAT THE NEEDLE SHEATH CAN BE PASSED THROUGH A CATHETER; SAID SHEATH BEING RESILIENTLY DISTORTABLE BEFORE ENTRY INTO A BODY TO PERFORM THE BIOPSY BUT CAPABLE OF NORMALLY RETAINING A PREDETERMINED SHAPE WHILE WITHIN THE BODY AND DURING BIOPSY SAMPLING, THE LENGTH OF SAID SHEATH BEING ADEQUATE TO ALLOW THE SAME TO EXTEND FROM AN EXTERIOR POINT TO THE VENTRICULAR SEPTUM VIA THE RIGHT EXTERNAL JUGULAR VEIN OF A PATIENT, SAID SHEATH HAVING A PROXIMAL END AND A DISTAL END; A HANDLE MEMBER FIXED TO SAID SHEATH AT THE PROXIMAL END THEREOF AND INCLUDING INDICATING MEANS PROJECTING LATERALLY RELATIVE TO SAID SHEATH; A FLEXIBLE WIRE EXTENDING THROUGH SAID SHEATH AND HAVING ONE END PORTION PROJECTING FROM THE PROXIMAL END THEREOF; A MANIPULATING MEMBER SECURED TO SAID ONE END PORTION OF SAID WIRE AND DISPOSED EXTERIORLY OF SAID SHEATH, WHEREBY SAID WIRE CAN BE MOVED RECTILINEARLY RELATIVE TO SAID SHEATH; AND SPECIMEN CUTTING MEANS SECURED TO THE OTHER END PORTION OF SAID WIRE FOR CLEANLY SEVERING A TISSUE SAMPLE, SAID CUTTING MEANS COMPRISING TWO BLADE PORTIONS MOVABLE TOWARD EACH OTHER TO COOPERATIVELY GRIP AND CLEANLY SEVER THE TISSUE SAMPLE; THE LENGTH OF SAID WIRE BEING GREATER THAN THE LENGTH OF SAID SHEATH BY AN AMOUNT SUCH THAT SAID MANIPULATING MEMBER CAN BE MOVED BETWEEN A FIRST POSITION SPACED FROM THE PROXIMAL END OF SAID SHEATH TO A POSITION ADJACENT THE PROXIMAL END OF THE SHEATH IN ORDER TO CAUSE SAID CUTTING MEANS TO REMOVE A SPECIMEN OF CARDIAC MUSCLE WITHOUT ARTIFACT, SAID CUTTING MEANS BEING RETRACTED WITHIN THE DISTAL END PORTION OF SAID SHEATH WHEN SAID MANIPULATING MEMBER OCCUPIES SAID FIRST POSITION; THE PORTION OF SAID SHEATH ADJACENT THE DISTAL END THEREOF BEING CURVED, WHEN SAID SHEATH IS IN ITS NORMAL PREDETERMINED SHAPE, IN A LATERAL DIRECTION, SAID INDICATING MEANS BEING ALIGNED WITH THE TIP OF SAID DISTAL END PORTION TO ENABLE THE USER TO ACCOMPLISH REMOTELY THE ACCURATE PLACEMENT OF SAID CUTTING MEANS ON THE LOWER VENTRICULAR SEPTUM. 